UK Authorizes Pfizer’s COVID-19 Vaccine in World First

In a watershed moment in the pandemic, the UK became the first Western nation to authorize a COVID-19 vaccine for emergency use, granting Pfizer clearance for its highly effective shot Wednesday, though the move drew immediate criticism from the EU.

The chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), June Raine, defended the agency’s temporary use authorization and said that it had thoroughly evaluated all the available data on quality, safety and effectiveness.

But the UK, which plans to begin vaccinations next week, was scolded by the European Commission for granting the emergency clearance. The commission argued that the EU’s conditional marketing authorization process involves a more thorough review and that the UK would have been better advised to wait for the European Medicines Agency (EMA) to make a decision.

The EMA’s expert advisory panel for vaccines — the Committee for Medicinal Products for Human Use (CHMP) — will meet on or before Dec. 29 to discuss Pfizer’s vaccine (DID, Dec. 2) and a decision is likely within days of that meeting.

“A conditional marketing authorization requires a higher level of evidence to be submitted and checked than a temporary use authorization,” a commission spokesperson told FDAnews. “A conditional marketing authorization is the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine before proceeding to mass vaccination.”

The MHRA is the first regulatory authority to grant emergency clearance for Pfizer’s mRNA-based vaccine, BNT162b2, which was co-developed with Germany’s BioNTech. The vaccine demonstrated a 95 percent effectiveness based on an interim analysis of 170 confirmed COVID-19 cases in an ongoing phase 3 trial. Only eight infections were reported in participants who received the vaccine rather than a placebo.

The UK has secured an advance order for 40 million doses of the Pfizer vaccine and the first shipment will arrive “in the coming days” with full delivery expected in the new year, Pfizer said.

Though Russia and China previously granted emergency clearance to the Sputnik V and Sinopharm vaccines, respectively, their decisions and the vaccines themselves were met with skepticism in the West due to a lack of late-stage trial data.

The FDA is still reviewing trial data for the Pfizer/BioNTech vaccine, and the agency is expected to make a decision this month on an emergency clearance (DID, Nov. 19). The FDA’s advisory committee for vaccines will meet on Dec. 10 to discuss Emergency Use Authorization (EUA) for BNT162b2, and doses could roll out for high-priority patients the next day if the panel recommends approval. — James Miessler